CLASS I Device recall · Reported 9 Jul 2014 · FDA Enforcement Report

Langston Dual Lumen Catheters recalled by Vascular Solutions

Vascular Solutions is recalling Langston Dual Lumen Catheters, distributed nationwide in the US. The recall was initiated on 27 May 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Numbers: 569436, 569437, 569962, , 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, and 571727.

Quantity recalled8,580 total (US 5714)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1981-2014
FDA event ID: 68489
Recalling firm: Vascular Solutions, Maple Grove, MN
Classification: Class I
Status: Terminated
Recall initiated: 27 May 2014
FDA classified: 3 Jul 2014
Reported: 9 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

27 May 2014	Recall initiated by company
3 Jul 2014	Classified by FDA	+37 days
9 Jul 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.

Product as listed by the FDA

Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.

Where it was distributed

Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.

Nationwide District of Columbia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Numbers: 569436, 569437, 569962, , 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, and 571727.

Where was it sold?

Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
28 Oct 2020Device	CLASS I	Langston Dual Lumen Catheter recalled by Vascular Solutions	Vascular Solutions	Other	52 states
28 Oct 2020Device	CLASS I	Langston Dual Lumen Catheter recalled by Vascular Solutions	Vascular Solutions	Other	52 states
28 Oct 2020Device	CLASS I	Langston Dual Lumen Catheter recalled by Vascular Solutions	Vascular Solutions	Other	52 states
28 Oct 2020Device	CLASS I	Langston Dual Lumen Catheter recalled by Vascular Solutions	Vascular Solutions	Other	52 states
6 May 2020Device	CLASS I	Langston Dual Lumen Catheter 6F recalled by Vascular Solutions	Vascular Solutions	Other	Nationwide

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